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Postoperative Effects of Intranasal Fentanyl, IV and IM Morphine in Children Undergoing Myringotomy

Postoperative Analgesic and Behavioral Effects of Intranasal Fentanyl, Intravenous Morphine and Intramuscular Morphine in Pediatric Patients Undergoing Bilateral Myringotomy and Placement of Ventilating Tubes

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01244126
Enrollment
171
Registered
2010-11-19
Start date
2008-05-31
Completion date
2011-05-31
Last updated
2016-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otitis Media

Keywords

otitis media, recurrent ear infections (otitis media)

Brief summary

The purpose of this study is to compare the difference in effect of three clinically common methods of providing pain medication during surgery for ventilating tubes placed for recurring ear infections.The methods are fentanyl dripped in the nose, morphine injected in a muscle, and morphine injected in a vein.

Detailed description

Preoperative anxiety will be assessed by the modified Yale Preoperative Anxiety Scale (mYPAS) at two points - (1) prior to separating the patient from the caretaker and bringing the patient to the operating room and (2) on application of the facemask. In keeping with our current standard practice, the child will be brought to the OR without premedication, and anesthesia will be induced and maintained by having the child breath sevoflurane titrated up to 8 %, nitrous oxide 70 % and oxygen 30 % via a facemask. In keeping with the guidelines of the American Society of Anesthesiologists recommendations, standard monitoring of EKG, pulse oxymetry, blood pressure and skin temperature will be performed. After a satisfactory level of anesthesia has been achieved, intravenous access will be established. All patients will receive intranasal, IM and IV medications as assigned by a computer generated random number scheme.Group A -Intranasal Fentanyl 2 mcg/kg (0.04 ml/kg), Normal saline placebo IM and IV: Group B Intranasal normal saline (0.01 ml/kg) placebo, Morphine 0.1 mg/kg (0.01 ml/kg)IM and IV normal saline placebo (0.01 ml/kg); Group C- Intranasal Placebo - normal saline 0.04 ml/kg, IM normal saline Placebo 0.01 ml/kg and Morphine 0.1 mg/kg (0.01 ml/kg) IV. The surgeon will be asked to describe the condition of the middle ear (worst side) on a scale of 1-4 as described by Davis et al. (1 = no fluid; 2 = serous fluid; 3 = pus; and 4 = thick tenacious mucus-glue ear). The surgeon will also report any laceration of the ear canal. Induction time, surgery start and end time and arrival in PACU time will be recorded. In the postoperative care unit the pain score will be measured by the FLACC's pain scale (Face, Legs, Activity, Cry, Consolability), adverse emergence behavior will be measured by PAED scale described by Sikich et. al. (Pediatric Anesthesia Emergence Delirium Scale). Patients with pain scores greater than 4 will receive morphine 0.05 mg/kg IV, to be repeated once if the pain score remains greater than 4 after 10 minutes. Acetaminophen 10-15 mg/kg will be administered enterally for pain scores between 1-3. The incidence of oxygen desaturation (pulse oximetry values less than 95% for greater than 30 secs), emesis and need for pain rescue medication will be recorded. The times of arrival in PACU, eye opening, response to command, ambulation, discharge readiness, and actual discharge home will be recorded as well. Parental satisfaction with postoperative pain control and the overall experience will be measured on a 10-point (0= completely dissatisfied -10= completely satisfied) verbal rating scale. A postoperative survey will be conducted over the phone the following day. Time and dose of postoperative medications, quality and duration of sleep, appetite and incidence of nausea and vomiting, time patient returned to presurgical level of playing and normal behavior and parent satisfaction will be recorded.

Interventions

2mcg/kg fentanyl IN

DRUGmorphine IM

0.1 mg/kg morphine IM for postop pain

0.1 mg/kg morphine IV

Sponsors

Baylor College of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Months to 6 Years
Healthy volunteers
No

Inclusion criteria

* bilateral myringotomy

Exclusion criteria

* ASA greater than 2 * history of bleeding disorder/thrombocytopenia * history of allergy to morphine or fentanyl

Design outcomes

Primary

MeasureTime frameDescription
Maximum Postoperative Face, Legs, Activity, Cry and Consolability (FLACC) Pain Score.Upon arrival in the PACU, and at 5, 10, 15, 30, 45, 60 minutes and at dischargeFLACC assigns 0-2 points for each of 5 categories (face, legs, activity, cry, consolability)and sums these points to give a total score where high scores indicate worse pain (Paediatr Anaesth 2006; 16: 258-65)

Secondary

MeasureTime frameDescription
Maximum PAED ScoreUpon arrival in the PACU, and at 5, 10, 15, 30, 45, 60 minutes and at dischargeMaximum score on the Pediatric Anesthesia Emergence delirium scale. This has 5 items ranging from 1-4 and higher scores indicate greater emergence delirium. 1\. eye contact with care giver ,score 1-4, purposeful actions 1-4, aware of surrounding 1-4,restless 1-4, inconsolable 1-4, Maximum score 20.

Countries

United States

Participant flow

Recruitment details

Children scheduled for bilateral myringotomy and insertion of tubes at TCH from September 2008 to Feb 2011

Pre-assignment details

1531 children screened, 1143 excluded as not qualifying, 217 declined to participate

Participants by arm

ArmCount
IM Morphine
0.1 mg/kg morphine IM
59
IV Morphine
0.1 mg/kg morphine IV
55
Fentanyl IN
Intranasal fentanyl 2 mcg/kg IN
57
Total171

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyProtocol Violation339

Baseline characteristics

CharacteristicIM MorphineIV MorphineFentanyl INTotal
Age, Categorical
<=18 years
59 Participants55 Participants57 Participants171 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants0 Participants
Age, Continuous2.3 years
STANDARD_DEVIATION 1.6
2.7 years
STANDARD_DEVIATION 2.2
2.4 years
STANDARD_DEVIATION 1.7
2.4 years
STANDARD_DEVIATION 1.8
ASA Physical Status in Patients who completed study
ASA Physical Status 1
12 Participants11 Participants7 Participants30 Participants
ASA Physical Status in Patients who completed study
ASA Physical Status 2
44 Participants41 Participants41 Participants126 Participants
Gender in patients completing study
Female
21 Participants15 Participants19 Participants55 Participants
Gender in patients completing study
Male
35 Participants37 Participants29 Participants101 Participants
Number completing study56 participants52 participants48 participants156 participants
Region of Enrollment
United States
59 participants55 participants57 participants171 participants
Sex: Female, Male
Female
23 Participants17 Participants24 Participants64 Participants
Sex: Female, Male
Male
36 Participants38 Participants33 Participants107 Participants
Weight in Kgs14.1 Kgs
STANDARD_DEVIATION 7.3
15.2 Kgs
STANDARD_DEVIATION 8.1
13.3 Kgs
STANDARD_DEVIATION 4.6
14.2 Kgs
STANDARD_DEVIATION 6.9

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 580 / 530 / 53
serious
Total, serious adverse events
0 / 580 / 530 / 53

Outcome results

Primary

Maximum Postoperative Face, Legs, Activity, Cry and Consolability (FLACC) Pain Score.

FLACC assigns 0-2 points for each of 5 categories (face, legs, activity, cry, consolability)and sums these points to give a total score where high scores indicate worse pain (Paediatr Anaesth 2006; 16: 258-65)

Time frame: Upon arrival in the PACU, and at 5, 10, 15, 30, 45, 60 minutes and at discharge

Population: Analysis was performed on per protocol basis excluding patients with protocol violations

ArmMeasureValue (MEAN)Dispersion
IM MorphineMaximum Postoperative Face, Legs, Activity, Cry and Consolability (FLACC) Pain Score.2.9 units on a scaleStandard Deviation 3
IV MorphineMaximum Postoperative Face, Legs, Activity, Cry and Consolability (FLACC) Pain Score.2.7 units on a scaleStandard Deviation 3.2
Fentanyl INMaximum Postoperative Face, Legs, Activity, Cry and Consolability (FLACC) Pain Score.2.0 units on a scaleStandard Deviation 2.7
Comparison: The primary outcome of the study was the maximum postoperative FLACC pain score.p-value: 0.21Kruskal-Wallis
Secondary

Maximum PAED Score

Maximum score on the Pediatric Anesthesia Emergence delirium scale. This has 5 items ranging from 1-4 and higher scores indicate greater emergence delirium. 1\. eye contact with care giver ,score 1-4, purposeful actions 1-4, aware of surrounding 1-4,restless 1-4, inconsolable 1-4, Maximum score 20.

Time frame: Upon arrival in the PACU, and at 5, 10, 15, 30, 45, 60 minutes and at discharge

Population: The sample size was based on the assumption that the pain scores in the intranasal fentanyl group would be similar to those in previously published data

ArmMeasureValue (MEAN)Dispersion
IM MorphineMaximum PAED Score6.1 units on a scaleStandard Deviation 6.2
IV MorphineMaximum PAED Score6.3 units on a scaleStandard Deviation 6.7
Fentanyl INMaximum PAED Score4.6 units on a scaleStandard Deviation 5.8
Comparison: Kruskall Wallis testp-value: 0.34Kruskal-Wallis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026